Senior Quality Compliance Leader - Electrophysiology

Abbott; Plymouth (MN); On-site; USD 129,000 - 259,000; Full time

Benefits offered by this job

Healthcare benefits

Tuition reimbursement

Retirement plan

Job summary

Abbott in Plymouth, MN (EP Electrophysiology) seeks a Senior Manager of Quality Compliance to lead global quality and regulatory programs, ensuring audit readiness and robust compliance across sites. You will shape strategy, mentor teams, and drive improvements in a highly regulated medical device environment.

The role requires extensive experience in quality systems, regulatory affairs, and cross-functional leadership within a global organization, with a focus on scaling compliance for the EP

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Industrial Technology, or a related field.
• 13+ years of combined experience in Quality, Compliance, Manufacturing Operations, Regulatory Affairs, or related functions.
• Experience leading large, cross-functional programs in a regulated industry.
• Strong knowledge of Quality Management Systems and compliance processes.
• Previous management experience.
• Experience influencing stakeholders and driving results in a matrixed global organization.
• Excellent communication, presentation, and executive-facing leadership skills.

Responsibilities

• Lead quality compliance programs, including external audit support, inspection readiness activities, and quality system effectiveness initiatives.
• Develop and execute compliance strategies for the EP business, strengthening audit capability across sites and functions.
• Manage and support Health Hazard Evaluation (HHE), RRE/SRE, field action, and remediation activities to ensure timely and compliant execution.
• Lead and mentor team members while partnering with leadership and cross-functional stakeholders to achieve compliance objectives.
• Drive site audit readiness for FDA & NB and support Field Action Strategy.
• Advance the Global Quality Management System and governance of quality programs.

Education

Bachelor's degree in Engineering, Life Sciences, Industrial Technology, or a related field

Job description

Abbott in Plymouth, MN (EP Electrophysiology) seeks a Senior Manager of Quality Compliance to lead global quality and regulatory programs, ensuring audit readiness and robust compliance across sites. You will shape strategy, mentor teams, and drive improvements in a highly regulated medical device environment.

The role requires extensive experience in quality systems, regulatory affairs, and cross-functional leadership within a global organization, with a focus on scaling compliance for the EP